Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 296 for:    ASPIRIN AND clopidogrel AND dual

Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE) (DES-LATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01186146
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : March 20, 2014
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Tracking Information
First Submitted Date  ICMJE August 17, 2010
First Posted Date  ICMJE August 23, 2010
Last Update Posted Date March 20, 2014
Study Start Date  ICMJE August 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
The composite of cardiac death, myocardial infarction, or stroke [ Time Frame: at 2 year after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01186146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2012)
  • death [ Time Frame: at 2 year after randomization ]
  • myocardial infarction [ Time Frame: at 2 year after randomization ]
  • stroke [ Time Frame: at 2 year after randomization ]
  • stent thrombosis [ Time Frame: at 2 year after randomization ]
  • Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding [ Time Frame: at 2 year after randomization ]
  • Target Vessl revascularization [ Time Frame: at 2 year after randomization ]
  • Target Lesion Revascularization [ Time Frame: at 2 year after randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
  • death [ Time Frame: at 2 year after randomization ]
  • myocardial infarction [ Time Frame: at 2 year after randomization ]
  • stroke [ Time Frame: at 2 year after randomization ]
  • stent thrombosis [ Time Frame: at 2 year after randomization ]
  • Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding [ Time Frame: at 2 year after randomization ]
  • repeat revascularization [ Time Frame: at 2 year after randomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)
Official Title  ICMJE Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events
Brief Summary This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.
Detailed Description This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Aspirin monotherapy
    stopping clopidogrel at 1 year after DES
  • Drug: Aspirin,Clopidogrel
    continue aspirin and clopidogrel 1year after DES
    Other Name: Aspirin,Clopidogrel Dual antiplatelet therapy
Study Arms  ICMJE
  • Active Comparator: Aspirin
    Aspirin monotherapy (stopping clopidogrel at 1 year after DES)
    Intervention: Drug: Aspirin monotherapy
  • Experimental: Aspirin,Clopidogrel
    Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES)
    Intervention: Drug: Aspirin,Clopidogrel
Publications * Lee CW, Ahn JM, Park DW, Kang SJ, Lee SW, Kim YH, Park SW, Han S, Lee SG, Seong IW, Rha SW, Jeong MH, Lim DS, Yoon JH, Hur SH, Choi YS, Yang JY, Lee NH, Kim HS, Lee BK, Kim KS, Lee SU, Chae JK, Cheong SS, Suh IW, Park HS, Nah DY, Jeon DS, Seung KB, Lee K, Jang JS, Park SJ. Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial. Circulation. 2014 Jan 21;129(3):304-12. doi: 10.1161/CIRCULATIONAHA.113.003303. Epub 2013 Oct 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2010)
5000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
  • 2. Time for index PCI to randomization: 12-18 months

Exclusion Criteria:

  • Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
  • Concomitant vascular disease requiring long-term use of clopidogrel
  • Other established indications for clopidogrel therapy (e.g., a recent ACS).
  • Noncardiac coexisting conditions with a life expectancy < 1 year.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01186146
Other Study ID Numbers  ICMJE 2007-0186
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seung-Jung Park, CardioVascular Research Foundation, Korea
Study Sponsor  ICMJE Seung-Jung Park
Collaborators  ICMJE CardioVascular Research Foundation, Korea
Investigators  ICMJE
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
PRS Account CardioVascular Research Foundation, Korea
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP